BEUDAMED
    FDA Recall Terminated

    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

    Recall: Z-2292-2013 · Initiated April 9, 2013

    Recall

    Recall Number
    Z-2292-2013
    Event Number
    65043
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 9, 2013
    Posted
    September 27, 2013
    Terminated
    June 17, 2014
    Address
    399 Jefferson Rd, Parsippany, NJ, 07054-3707

    Description

    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

    Reason

    Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

    Action

    Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013.

    Distribution

    Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.

    Quantity

    1730 units